Two-stage estimation on adjustment for cross-over in oncology trials
10.12092/j.issn.1009-2501.2021.04.006
- Author:
Quanji YU
1
;
Senmiao NI
1
;
Min YANG
1
;
Zihang ZHONG
1
;
Jiawei ZHOU
1
;
Lixin CAI
1
;
Jianling BAI
1
;
Hao YU
1
Author Information
1. Department of Biostatistics, School of Public Health, Nanjing Medical University
- Publication Type:Journal Article
- Keywords:
Accelerated failure time model;
Cross-over;
Two-stage estimation
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2021;26(4):395-400
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To investigate the application of two-stage estimation (TSE) on adjustment for treatment switch in oncology trials. METHODS: The theory and implementation of TSE method was described, and was applied to adjust the data from a two-arm randomized controlled trial of anti-tumor drugs. The changes of survival curves and hazard ratio of two groups after adjustment for cross-over were evaluated. In addition, the results of two-stage estimation and rank preserving structural failure time model (RPSFT) were compared. RESULTS: After adjustment for cross-over using TSE methods, the results showed that the median survival time of control group was shorter than the original one, and the hazard ratio was lower than the observed value. Moreover, TSE method showed similar results to rank preserving structural failure time model. CONCLUSION: The TSE method is relatively simple to use, reliable and has a good practice property in cross-over analysis of oncology trials. At the same time, it is necessary to pay attention to its application scopes.
